Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Decentralized Clinical Trials Among Topics Slated For CDER Guidance In 2020

Executive Summary

US FDA's to-do list also includes guidances on development of non-opioid analgesics and cannabis compounds, evaluation of generic therapeutic equivalence, and pediatric product development.

You may also be interested in...



Decentralized Trials Guidance May Reflect US FDA’s Lessons Learned During COVID-19

Work on guidance that was originally expected in 2020 continues as the agency and industry learn more about the utility and spectrum of decentralized trials as a result of the novel coronavirus pandemic.

COVID-19 And IP: Companies Are 'Taking A Chance' Sharing Clinical Trial Details

While companies often keep clinical trial endpoints a secret, FDA's Peter Marks notes that may not be the case with COVID-19 vaccines; CDER's Patrizia Cavazzoni says agency may expand de-centralized trials.

FDA Looks Ahead To Complex Product-Specific Guidances

The agency offers a glimpse of its regulatory agenda, although several have been carried over through multiple list updates.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

OM006665

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel